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Oxygen 98%: Ph. Eur. receives valuable feedback on new oxygen quality

European Pharmacopoeia
Public enquiry
15 June 2020
Strasbourg, France

The EDQM would like to warmly thank its stakeholders for their invaluable feedback and their commitment to the work of the European Pharmacopoeia (Ph. Eur.).

About 40 different interested parties, including gas producers and industry associations, National Pharmacopoeia Authorities (NPAs), hospitals, consultants, dispensing pharmacists, healthcare establishments and manufacturers of oxygen generators commented on the news item entitled “Oxygen 98%: Ph. Eur. requests feedback on new oxygen quality to boost availability”, published on 16 April 2020, and on the corresponding draft monograph. This ground-level feedback was essential and helped the NPAs decide how best to proceed with the monograph on Oxygen (98 per cent) (3098). It was clear from the comments that co-operation between the national authorities, hospitals and gas producers was excellent during the COVID-19 crisis and that no oxygen shortages had occurred. The use of oxygen generators in this context appeared to be very limited.

Although the urgent elaboration of a monograph on Oxygen (98 per cent) (3098) is no longer seen as absolutely necessary, the monograph itself is still considered useful to cover the needs of remote areas and other settings. The NPAs have therefore agreed that the Ph. Eur.’s Expert Group on Medicinal Gases should examine all the comments received very thoroughly and continue elaboration of the monograph Oxygen (98 per cent) (3098) according to standard procedures.

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